Stefan Zeuzem (Saarland University Hospital, Hamburg Germany) and colleagues reported on this study at AASLD (Oct 25-29, 2003), which examines treatment of individuals with chronic hepatitis C who have normal ALT.

Zeuzem provided this background. 25-45% of patients with chronic hepatitis C have "normal" ALT levels. Significant liver disease is possible. Patients with normal ALT were excluded from previous pivotol trials. There has been a concern about a risk for ALT flares in patients who are treated and have normal ALT. Current guidelines recommend against treatment in this subgroup until data from large multicenter trials become available.

Summary

The authors concluded that this study showed similar efficacy and safety in patients with chronic HCV and persistently normal or elevated ALT. Pegasys plus RBV therapy is not associated with ALT flares. Treatment duration shown in previous studies was shown here –24 weeks for genotyope 1 and 48 wks for genotyoe 2. There were further reductions below baseline levels in ALT for sustained responders. The authors stated that the treatment for patients with chronic hepatitis C should rely on the probability of viral eradication, symptoms, histology, anticipated progression of disease, and/or the risk of transmission (eg, health care workers) rather than on a biochemical parameter.

STUDY POPULATION

Patients had chronic HCV and persistently normal ALT on 3 occassions within 6-18 months before baseline.

514 patients were randomized (3:3:1) to group A (PEG+RBV), n=220 for 24 weeks, group B (PEG-RBV), n=221 for 48 weeks, and Group C, n=73, were untreated. There is a 24 weeksfollowup period after the end of treatment.

All patients showed some decline in ALT levels, which was sustained and increased for SVRs with median ALT levels as half that seen at baseline. Relapse patients saw increased ALT after treatment stopped that did not exceed baseline ALT levels. Viral nonresponders saw ALT increase on average 4-8 weeks after starting therapy following an initial ALT decline, and the increase also did not exceed baseline ALT levels. These patterns of response were similar for patients treated for either 24 or 48 weeks.

The authors concluded that the treatment for patients with chronic hepatitis C should rely on the probability of viral eradication, symptoms, histology, anticipated progression of disease, and/or the risk of transmission (eg, health care workers) rather than on a biochemical parameter.